DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In light of the amendments, the previous claim objections have been withdrawn.
In light of the amendments, the 112(b) rejections have been withdrawn.
In light of the amendments, claims 1-5 and 10-14 are rejected under 35 U.S.C. 112(a).
In light of the amendments, claims 3-4 and 12-13 are rejected under 35 U.S.C. 112(b).
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
In light of the amendments, the previous 35 U.S.C. 102/103 rejections are withdrawn.
Notice to Applicant
In the amendment dated 01/08/2026, the following has occurred: claims 1, 3, 6-10, and 12-13 have been amended; claims 2, 4-5, 11, and 14 remain unchanged; and no new claims have been added.
Claims 1-14 are pending.
Effective Filing Date: 03/09/2022
Response to Arguments
Claim Objections:
Applicant amended the claims to overcome the previous claim objections. Examiner withdraws these objections.
35 U.S.C. 112(b) Rejections:
Applicant amended the claims to overcome the previous claim rejections. Examiner withdraws these rejections.
35 U.S.C. 101 Rejections:
Applicant argues that the amended claims integrate the abstract idea into a practical application that improves the operation of a clinical diagnostic analyzer system, thus those claims are patient-eligible under Step 2A, Prong Two of the USPTO eligibility framework. Applicant stresses that there are operations performed automatically by an analyzer and server processors, without human intervention. Having operations be performed without human intervention does not necessarily provide a practical application as this can be a product of merely applying an abstract idea using computing components.
Applicant also argues that the system is being improved via feedback. Data is being updated with new data, thus the improvement appears to be directed towards the abstract idea involving data analysis. Improving the accuracy of a model by supplying it with specific data is not an improvement to how the model is trained within the meaning of Desjardins (see quotations from Recentive, infra). This is how all machine learning models are optimized (i.e., select training data, train the model, compare the output to validation data, receive feedback, adjust the parameters of the training data according to the comparison/feedback, and repeat until an accuracy threshold is met). Put another way, the particular way the machine learning model of applicant’s invention uses the data to train itself is not improved, which is the holding of Desjardins. Applicant is merely improving the accuracy of the model by optimizing the data selected/used by the model. Improving the accuracy of a model is not an improvement by any measure in MPEP 2106.
Applicant further argues that the claims cannot be practically performed within the human mind. Examiner however directed the abstract idea towards certain methods or organizing human activity.
Lastly, Applicant states that the claims recite an inventive concept under Step 2B. The system that dynamically adapts analytical precision in a manner not achievable by conventional quality-control or statistical reporting systems. Examiner however respectfully disagrees based on the above explanation. The improvement of precision based on the change in data is not something which provides significantly more than the abstract idea.
35 U.S.C. 102/103 Rejections:
Applicant amended the claims to overcome the previous 102/103 claim rejections. Examiner withdraws these rejections.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 10 recite the addition of a second pre-determined range which is different than the first predetermined range (from claim 1). There is insufficient support in the specification for this second range, leading Examiner to question if Applicant had possession over the claimed invention at the time of tiling.
Claim 1 also recites the steps of “loading and evaluating…” and “comparing…” before “accessing…” and “obtaining…”. FIG. 6 however eludes to the “accessing…” and “obtaining…” steps occurring before the “loading and evaluating…” and “comparing…” steps. There does not seem to be support for the claims in the present ordering of the limitations, leading Examiner to question if Applicant had possession over the claimed invention at the time of tiling.
Claims 1, 6, and 10 also recite either “profile parameters” or “algorithmic parameters” but the specification does not provide support for these terms, leading Examiner to question if Applicant had possession over the claimed invention at the time of filing.
Claims 2-5, 7-9, and 11-14 are rejected as being dependent on claims 1, 6, and 10.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4 and 12-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3-4 and 12-13 recite “a second predetermined range”, but the independent claims from which these claims are dependent on also recite a second predetermined range. It is unclear if these are the same ranges or if these are different ranges, thus these claims are deemed indefinite. Examiner is interpreting that these are the same ranges.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-9 are drawn to analyzers and claims 10-14 are drawn to a system, each of which is within the four statutory categories. Claims 1-14 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites a clinical diagnostic analyzer for dynamically adjusting analytical precision in a clinical diagnostic test, comprising:
a) a processor;
b) measurement hardware in communication with the processor and comprising a photometric, spectrometric, or electrochemical sensor configured to generate an electronic measurement signal corresponding to an analyte response;
c) a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations comprising:
1) loading and evaluating a patient specimen by automatically acquiring the electronic measurement signal from the measurement hardware to ascertain a first value for the specimen;
2) comparing the first value to determine if the first value is within a first predetermined range;
3) accessing a stored precision profile data file comprising the first predetermined range and a second predetermined range, wherein the second predetermined range differs from the first predetermined range;
4) obtaining from the stored precision profile data file a predetermined number of re-evaluations and profile parameters associated with an analyte type;
5) upon determining the first value is within the first predetermined range, dynamically selecting, based on the profile parameters obtained from the precision profile data file, the predetermined number of re-evaluations, revaluating the patient specimen a predetermined number of times to determine a second value and reporting the second value to a user; and
6) upon determining the first value is not within the first predetermined range, reporting the first value to a user;
7) wherein all comparisons, selections, and re-evaluations are automatically performed without human intervention; and
8) wherein the precision profile data file is periodically updated using peer- group data received from d) a server system.
Claim 1 recites, in part, performing the steps of 1) loading and evaluating a patient specimen by automatically acquiring the electronic measurement signal from the measurement hardware to ascertain a first value for the specimen, 2) comparing the first value to determine if the first value is within a first predetermined range, 3) accessing a stored precision profile data file comprising the first predetermined range and a second predetermined range, wherein the second predetermined range differs from the first predetermined range, 4) obtaining from the stored precision profile data file a predetermined number of re-evaluations and profile parameters associated with an analyte type, 5) upon determining the first value is within the first predetermined range, dynamically selecting, based on the profile parameters obtained from the precision profile data file, the predetermined number of re-evaluations, revaluating the patient specimen a predetermined number of times to determine a second value and reporting the second value to a user, 6) upon determining the first value is not within the first predetermined range, reporting the first value to a user, and 8) wherein the precision profile data file is periodically updated using peer-group data. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim describes evaluating data and determining if a value is within a range or not within a range. Independent claim 10 recites similar limitations and is also directed to an abstract idea under the same analysis.
Claim 6 recites a clinical diagnostic analyzer for dynamically adjusting analytical precision in a clinical diagnostic test, comprising:
a) a processor;
b) measurement hardware in communication with the processor and configured to generate an electronic measurement signal corresponding to an analyte response;
c) a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations comprising:
9) loading and evaluating a patient specimen by generating and digitizing the electronic measurement signal to ascertain a first value for the specimen;
10) comparing the first value to determine if the first value is within a first predetermined range;
11) upon determining the first value is within the first predetermined range, selecting, based on a precision profile data file, the predetermined number of re-evaluations and revaluating the patient specimen to determine a second value for the specimen;
12) calculating a precision value based on the first value and the second value, wherein the calculation of the precision value comprises automatically applying stored algorithmic parameters retrieved from the precision profile data file;
13) reporting the precision value to a user;
14) wherein all operations are executed by the processor and are not performed manually; and
15) wherein the stored precision profile data file is updated using peer-group data generated by a plurality of analyzers.
Claim 6 recites, in part, performing the steps of 9) loading and evaluating a patient specimen by generating and digitizing the electronic measurement signal to ascertain a first value for the specimen, 10) comparing the first value to determine if the first value is within a first predetermined range, 11) upon determining the first value is within the first predetermined range, selecting, based on a precision profile data file, the predetermined number of re-evaluations and revaluating the patient specimen to determine a second value for the specimen, 12) calculating a precision value based on the first value and the second value, wherein the calculation of the precision value comprises automatically applying stored algorithmic parameters retrieved from the precision profile data file, 13) reporting the precision value to a user, and 15) wherein the stored precision profile data file is updated using peer-group data generated by a plurality of analyzers (which may be people). These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim describes evaluating data and determining if a value is within a range or not within a range.
Depending claims 2-5, 7-9, and 11-14 include all of the limitations of claims 1, 6, and 10, and therefore likewise incorporate the above described abstract idea. Depending claims 4, 9, and 13 add the additional step of “generating an alert to a user when the reported first value or the reported second value are within a second predetermined range”. Additionally, the limitations of depending claims 2-3, 5, 7-8, 11-12, and 14 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-5, 7-9, and 11-14 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 6, and 10 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using d) a server system/a plurality of peer group systems, wherein each peer group system comprises: (from claim 10) d1) a server comprising a server processor, a memory and a database, wherein the server is in communication with servers of other peer group systems, (from claim 10) and d2) a plurality of clinical diagnostic analyzers in communication with the server, wherein each of the plurality of clinical diagnostic analyzers comprises: (from claim 10) a) a processor/an analyzer processor, b) measurement hardware in communication with the processor/analyzer processor and configured to generate electronic measurement signals from an analyte, and c) a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations to perform the claimed steps.
The claims also include the additional element steps of 7) “wherein all comparisons, selections, and re-evaluations are automatically performed without human intervention” and 14) “wherein all operations are executed by the processor and are not performed manually”.
The d) a plurality of peer group systems, wherein each peer group system comprises: d1) a server comprising a processor, a memory and a database, wherein the server is in communication with servers of other peer group systems, and d2) a plurality of clinical diagnostic analyzers in communication with the server, wherein each of the plurality of clinical diagnostic analyzers comprises: a) a processor, b) measurement hardware in communication with the processor and configured to generate electronic measurement signals from an analyte, and c) a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations in these steps and the additional element step of 7) “wherein all comparisons, selections, and re-evaluations are automatically performed without human intervention” and 14) “wherein all operations are executed by the processor and are not performed manually” are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification, paragraphs [0028] – [0031] where there are generic computing component for these components, see MPEP 2106.05(f)).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using d) a server system/a plurality of peer group systems, wherein each peer group system comprises: (from claim 10) d1) a server comprising a server processor, a memory and a database, wherein the server is in communication with servers of other peer group systems, (from claim 10) and d2) a plurality of clinical diagnostic analyzers in communication with the server, wherein each of the plurality of clinical diagnostic analyzers comprises: (from claim 10) a) a processor/an analyzer processor, b) measurement hardware in communication with the processor/analyzer processor and configured to generate electronic measurement signals from an analyte, and c) a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations to perform the claimed steps and the additional element steps of 7) “wherein all comparisons, selections, and re-evaluations are automatically performed without human intervention” and 14) “wherein all operations are executed by the processor and are not performed manually” amount to no more than mere instructions to apply the exception using generic computer components that do not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity. Specifically, MPEP 2106.05(f) recites that the following limitations are not significantly more:
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The current invention reports values to a user utilizing d) a server system/a plurality of peer group systems, wherein each peer group system comprises: (from claim 10) d1) a server comprising a server processor, a memory and a database, wherein the server is in communication with servers of other peer group systems, (from claim 10) and d2) a plurality of clinical diagnostic analyzers in communication with the server, wherein each of the plurality of clinical diagnostic analyzers comprises: (from claim 10) a) a processor/an analyzer processor, b) measurement hardware in communication with the processor/analyzer processor and configured to generate electronic measurement signals from an analyte, and c) a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations and the additional element steps of 7) “wherein all comparisons, selections, and re-evaluations are automatically performed without human intervention” and 14) “wherein all operations are executed by the processor and are not performed manually”, thus these computing components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-14 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684
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